Taxespira (previously Docetaxel Hospira UK Limited )

docetaxel

About

This is a summary of the European public assessment report (EPAR) for Taxespira. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Taxespira.

For practical information about using Taxespira, patients should read the package leaflet or contact their doctor or pharmacist.

Taxespira is a cancer medicine used to treat the following types of cancer:

breast cancer. Taxespira can be used on its own after other treatments have failed. It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;

non-small-cell lung cancer. Taxespira can be used on its own after other treatments have failed. It can also be used with cisplatin (another cancer medicine) in patients who have not yet received any treatment for their cancer;

prostate cancer, when the cancer does not respond to hormonal treatment. Taxespira is used with prednisone or prednisolone (anti-inflammatory medicines);

gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Taxespira is used with cisplatin and 5-fluorouracil (other cancer medicines);

head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Taxespira is used with cisplatin and 5-fluorouracil.

Taxespira contains the active substance docetaxel and is a ‘generic medicine’. This means that Taxespira is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Taxotere.

Taxespira is used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.

Taxespira is available as a concentrate for solution for infusion (drip) into a vein and is given as a one-hour infusion every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Taxespira is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxespira infusion.

The active substance docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton’ is dismantled to allow the cell to divide. By keeping the skeleton intact the cells cannot divide and they eventually die. Docetaxel also affects non‑cancer cells such as blood cells, which can cause side effects.

The company provided data from the published literature on docetaxel. The company also showed that Taxespira solution for infusion has comparable quality to that of Taxotere. No additional studies in humans were needed as Taxespira is a generic medicine that is given by infusion and contains the same active substance as Taxotere.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Taxespira has been shown to be comparable to Taxotere. Therefore, the CHMP’s view was that, as for Taxotere, the benefit outweighs the identified risk. The Committee recommended that Taxespira be approved for use in the EU.

A risk management plan has been developed to ensure that Taxespira is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taxespira, including the appropriate precautions to be followed by healthcare professionals and patients.

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Pharmacotherapeutic group

Therapeutic indication

Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

operable node-positive breast cancer;

operable node-negative breast cancer.

For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.

Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.

Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small cell lung cancer

Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.